MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-07 for COULTER GEN-S SYSTEM 6605381 manufactured by Beckman Coulter, Inc..
[15578877]
The customer contacted beckman coulter, inc. (bec) to report erroneously high white blood cell (wbc) results for three (3) patient samples on their coulter gen-s system. The erroneous wbc results were reported outside of the laboratory. There was no impact to patient treatment. Quality controls (qc) were assayed before and after the event. All qc results recovered within the laboratory's established ranges. The three patient samples were reassayed on another analyzer in the laboratory (coulter lh 750 hematology analyzer). Lower wbc results were obtained. Amended reports were generated and reported outside of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
[15945317]
Patient number 1 and number 2 were whole blood samples from bone marrow patients. The sample from patient number 3 was a whole blood normal patient sample. A manual scan was performed on patient number one to verify the wbc results. Patient number 2 had a second sample drawn. A field service engineer was dispatched to the customer's site. The fse replaced the diluent dispensers and wbc bath. The fse also bleached the wbc aperture modules to remove build-up. Following the repairs, the fse verified the performance of the analyzer per established procedures. The root cause is unknown but may be related to hardware replaced during servicing of the analyzer. This reportable event was identified during a retrospective review conducted between january 01, 2008 and october 23, 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01651 |
| MDR Report Key | 2320077 |
| Report Source | 05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2009-09-09 |
| Date of Event | 2009-09-06 |
| Date Mfgr Received | 2009-09-09 |
| Device Manufacturer Date | 1998-06-01 |
| Date Added to Maude | 2012-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER GEN-S SYSTEM |
| Product Code | GKL |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 6605381 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-07 |